NINDS, NIH BPN, NIH HEAL AND OTHER NIH NEUROSCIENCE-FOCUSED DRUG DISCOVERY AND DEVELOPMENT PROGRAMS WITH TOXICOLOGY CONSULTING SERVICES

NINDS、NIH BPN、NIH Heal 和其他 NIH 神经科学重点药物发现和开发计划以及毒理学咨询服务

• 批准号: 10721114
• 负责人: STEVE DUDDY
• 金额: $ 2.4万
• 依托单位: CERTARA USA, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2023-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10721114
• 关键词: Address; Biological Assay; Biological Products; Clinical; Clinical Research; Consult; Contractor; Data; Development; Development Plans; Electronic Mail; Feedback; In Vitro; Logistics; National Institute of Neurological Disorders and Stroke; Neurosciences; Oligonucleotides; Pharmacology; Pharmacology Study; Pharmacology and Toxicology; Program Development; Resources; Role; Services; Strategic Planning; Testing; Toxicology; United States National Institutes of Health; design; drug development; drug discovery; healing; in silico; in vivo Model; lead optimization; member; model development; nervous system disorder; pharmacokinetics and pharmacodynamics; pre-clinical; programs; safety study; screening; symposium

Toxicology SME(s) Toxicology SME consultants will be expected to provide senior-level expertise and contribute feedback and guidance on projects to the NIH and to LDT members through conference calls and by email. The role of the consultants may include but are not limited to the following responsibilities and tasks: a) Help establish toxicology endpoints and milestones for a project, recommend bioassays to be incorporated into a testing funnel or development plan, design toxicology and pharmacology studies, and interpret data delivered by CROs. b) In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND enabling, and clinical studies c) Serve as a resource to the LDT for toxicology requirements, pharmacology and logistics to conduct biologics development activities for biologics from the preclinical stage through to the initial clinical stage d) Serve as the toxicology expert in order to identify potential developmental challenges and suggest strategies to address these challenges e) Collaborate on design of investigative toxicology studies in support of biologics development f) Review toxicology sections of regulatory filings provided by CROs or PIs g) Collaborate on the design of investigative studies in support of biologics development. h) Provide expert support of preclinical strategy development including that for neurological diseases i) Support in vitro and in vivo model development for neurological disease j) Support design and interpretation of in silico analyses and in vitro/ ex vivo screening strategies for oligonucleotides k) Support of design PK/PD and toxicology safety studies

毒理学SME 毒理学SME顾问将通过电话会议和电子邮件向NIH和LDT成员提供高级专业知识，并就项目提供反馈和指导。顾问的角色可能包括但不限于以下职责和任务： a）、 帮助建立项目的毒理学终点和里程碑，推荐将生物测定纳入测试漏斗或开发计划，设计毒理学和药理学研究，并解释CRO提供的数据。 B） 与其他顾问、承包商和NIH工作人员合作，提供建议、战略规划和管理项目，以促进先导药物优化、IND启用和临床研究 c）、 作为LDT的毒理学要求、药理学和物流资源，从临床前阶段到初始临床阶段开展生物制剂的生物制剂开发活动 d）、 担任毒理学专家，以确定潜在的发展挑战，并提出应对这些挑战的策略 e）、 合作设计毒理学研究，以支持生物制剂开发 f）的 审查CRO或PI提供的监管文件的毒理学部分 g）的 合作设计调查性研究，以支持生物制剂的开发。 h）的 为临床前策略制定提供专家支持，包括神经系统疾病 （一） 支持神经系统疾病的体外和体内模型开发 j）、 支持计算机模拟分析和体外/离体分析的设计和解释 寡核苷酸的筛选策略 k）的 支持设计PK/PD和毒理学安全性研究